Agennix AG Announces Positive Results With Talactoferrin in Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial in Severe Sepsis

MARTINSRIED/MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX --(Marketwire - December 01, 2009) - Agennix AG (FRANKFURT: AGX) (XETRA: AGX) today reported results from the talactoferrin randomized, double-blind, placebo-controlled Phase 2 trial in severe sepsis. The trial evaluated talactoferrin versus placebo in 190 adult patients with severe sepsis enrolled at 25 leading centers across the U.S. Patients in both arms also received standard of care treatment for severe sepsis in an intensive care unit (ICU) setting. The trial achieved its primary endpoint of a reduction in 28-day all-cause mortality. The trial showed a 45% reduction in the 28-day all-cause mortality from 26.6% in the placebo arm to 14.6% in the talactoferrin arm (two-tailed p-value = 0.04, odds ratio by logistic regression analysis = 0.47).

“We are very excited to see such compelling results with talactoferrin in severe sepsis, a life-threatening and notoriously hard-to-treat disease,” said Rajesh Malik, M.D., Chief Medical Officer. “There are currently very limited treatment options available, with only one drug in the U.S. approved specifically for severe sepsis, a disease that results in hundreds of thousands of deaths each year in the U.S. and Europe alone. Given the strength of these clinical trial results, we plan to talk with regulatory authorities, as well as key opinion leaders and potential partners, about advancing talactoferrin for this indication.”

Patients were stratified by clinical site and by the presence or absence of cardiovascular dysfunction. Cardiovascular dysfunction is a major prognostic factor for severe sepsis. A similar number of patients had cardiovascular dysfunction in the two treatment groups. Sixty-four percent (64%) of patients (n=121) in the trial had cardiovascular dysfunction and 36% (n=69) did not. For those patients with cardiovascular dysfunction, 28-day all-cause mortality was 28.6% for the placebo arm and 22.4% for the talactoferrin arm. For patients who did not have cardiovascular dysfunction, 28-day all-cause mortality was 22.6% in the placebo arm compared to 2.6% in the talactoferrin arm. When the trial results were adjusted for cardiovascular dysfunction, the two-tailed p-value was 0.06, and the odds ratio was 0.49.

The above analyses were all conducted on an intent-to-treat (ITT), as treated basis, meaning that patients were evaluated based on the treatment they actually received (talactoferrin or placebo). An ITT as treated analysis is a method to address patient assignment errors in a way that mitigates the potential impact on the data analysis of a trial. In this study, the quality control process identified errors in drug labeling and randomization during the conduct of the trial that affected the drug assignment for some patients. That is why this analysis was used, following feedback from the U.S. Food and Drug Administration (FDA). To determine if the assignment error had an impact on the outcome of the trial, as recommended by the FDA, the Company conducted a sensitivity analysis evaluating 28-day all-cause mortality by excluding 22 patients who mistakenly received both talactoferrin and placebo. This analysis indicated that there was no apparent effect of the patient assignment errors on the outcome of the trial. The sensitivity analysis showed that 28-day all-cause mortality in the placebo arm was 25.9% compared to 15.1% for the talactoferrin arm.

Talactoferrin was shown to be very well tolerated in the study with no major differences in adverse events between the two treatment arms.

The study included 96 patients in the talactoferrin arm and 94 patients in the placebo arm. In addition, four patients were randomized but did not receive study drug due to withdrawal prior to receiving the first dose. All patients were centrally screened for eligibility prior to randomization. The arms were well balanced in terms of baseline characteristics.

The Phase 2 trial was primarily funded by a grant from the U.S. National Institutes of Health.

The Company plans to present data from the trial at an upcoming major medical meeting.

Conference call scheduled

The Company has scheduled a conference call to which participants may listen via live webcast, accessible through the Agennix Web site at www.agennix.com or via telephone. A replay will be available on the Web site following the live event. The call, which will be conducted in English, will be held on Wednesday, December 2, 2009 at 15:00 CET/9:00 AM ET. The dial-in numbers for the call are as follows:

Participants in Europe: 0049 69 667775756 0044 20 3003 2666 Participants in the U.S.: 1-646 843 4608 Please dial in 10 minutes before the beginning of the call. 

About severe sepsis

Sepsis is a condition involving known or suspected infection and generalized inflammation. The body’s normal response to an infection is to set off a limited chain reaction to fight the infection. In severe sepsis, this systemic response escalates into an overreaction by the body that leads to dysfunction of one or more organs. Each year, approximately 750,000 people in North America develop severe sepsis, and a similar number of people are affected in Europe. Those figures are expected to rise due to the aging population and other factors. Approximately 30% of people with severe sepsis are estimated to die annually from this condition in the U.S., and the U.S. Centers for Disease Control and Prevention indicates that sepsis is one of the top ten leading causes of death in the U.S. Patients suffering from severe sepsis must be hospitalized, often in an intensive care unit, and the medical costs to treat sepsis are estimated to be over $16 billion annually in the U.S. alone.

About talactoferrin

Talactoferrin is an oral novel targeted dendritic cell recruiter and activator being studied mainly for the treatment of cancer. Talactoferrin has demonstrated anti-cancer activity in two randomized, double-blind, placebo-controlled Phase 2 studies in non-small cell lung cancer (NSCLC). NSCLC is one of the most common types of cancer worldwide and the most frequent cause of cancer death. As a result of the promising results from Phase 2 studies, two Phase 3 studies with talactoferrin in NSCLC have been initiated. Talactoferrin has also shown activity in renal cell carcinoma, as well as severe sepsis. Talactoferrin has been shown to be very well tolerated in these patient populations. The Company also has a topical formulation of talactoferrin for wound healing.

About Agennix

Agennix AG is a publicly traded biopharmaceutical company focused on developing novel anti-cancer therapies. The Company was formed by the combination of GPC Biotech AG and Agennix Incorporated. The Company’s most advanced program is talactoferrin, an oral targeted therapy that is in Phase 3 clinical trials in non-small cell lung cancer. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase 1 testing; the oral platinum-based compound satraplatin; and a topical gel form of talactoferrin for wound healing. Agennix is a transatlantic company with sites in Munich, Germany; Princeton, New Jersey and Houston, Texas. For additional information, please visit the Agennix Web site at www.agennix.com.

This press release contains forward-looking statements, which express the current beliefs and expectations of the management of Agennix AG. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. There can be no guarantee that the Company will move talactoferrin forward in development for severe sepsis in a timely manner, if at all, or that talactoferrin will ultimately be approved for sale in any country. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release. Forward-looking statements speak only as of the date on which they are made and Agennix undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.